Politics and Regulation

Archive for Politics and Regulation

Are medical errors really the third most common cause of death in the U.S.?

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

Dr. Martin Makary claims that medical errors are now the third leading cause of death in the US. Is he correct?

Dr. Martin Makary claims that medical errors are now the third leading cause of death in the US. Is he correct?

It is an unquestioned belief among believers in alternative medicine and even just among many people who do not trust conventional medicine that conventional medicine kills. Not only does exaggerating the number of people who die due to medical complications or errors fit in with the world view of people like Mike Adams and Joe Mercola, but it’s good for business. After all, if conventional medicine is as dangerous as claimed, then alternative medicine starts looking better in comparison.

In contrast, real physicians and real medical scientists are very much interested in making medicine safer and more efficacious. One way we work to achieve that end is by using science to learn more about disease and develop new treatments that are as efficacious or more so than existing treatments with fewer adverse reactions (clinical equipoise). Another strategy is to use what we know to develop quality metrics against which we measure our practice. Indeed, I am heavily involved in just such an effort for breast cancer patients. Then, of course, we try to estimate how frequent medical errors are and how often they cause harm or even death. All of these efforts are very difficult, of course, but perhaps the most difficult of all is the last one. Estimates of medical errors depend very much on how medical errors are defined, and whether a given death can be attributed to a medical error depends very much on how it is determined whether a death was preventable and whether a given medical error led to that death.

Posted in: Politics and Regulation, Public Health, Quality Improvement, Science and Medicine

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Medical exemptions to vaccine mandates for sale after SB277! Get ’em before they’re gone!

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it's not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it’s not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

I realize that it’s a cliché to say so, but some clichés are true. Time really does fly. It’s hard to believe that a year ago California—and, by proxy, the rest of the country—was in the throes of a major political war over the bill SB277. SB277, you will recall, was a bill introduced into the California Assembly in the wake of the Disneyland Measles outbreak in early 2015 that eliminated non-medical exemptions to school vaccine mandates beginning with the 2016-2017 school year. Ultimately, SB277 passed and was signed into law by Governor Jerry Brown last July. It was an uncommon victory for science and public health, and already appears to be having a positive effect on vaccine uptake in kindergarten children.

Unfortunately but not unexpectedly, to say that the proposal and passage of SB277 into law drove the antivaccine movement into even greater fits of crazy in response is to put it mildly. It became a common trope on antivaccine websites and blogs to see SB277 compared to fascism, in particular the Holocaust. Robert F. Kennedy, Jr. and “Dr. Bob” Sears explicitly compared SB277 to the Holocaust. Truly, the Godwin was strong in the antivaccine movement. One particularly offensive meme that went around at the time consisted of antivaccinationists suggesting that SB277 was a major step in the direction of requiring unvaccinated children to wear a badge or armband to identify themselves, the way that the Nazis required Jews to wear badges or armbands with a yellow Star of David on them. One, Heather Barajas, even went so far as to be photographed with her children wearing such an “unvaccinated” badge and juxtapose that photo with photos of Jews from the Third Reich wearing yellow Stars of David.

Posted in: Homeopathy, Politics and Regulation, Public Health, Vaccines

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What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

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Reclassifying thyroid cancer and the willful misunderstanding of overdiagnosis

This is a panel showing some of the pathologic criteria for distinguishing invasive encapsulated follicular variant of papillary thyroid carcinoma from noninvasive. This is real science. Sayer Ji's rant is not.

This is a panel showing some of the pathologic criteria for distinguishing invasive encapsulated follicular variant of papillary thyroid carcinoma from noninvasive. This is real science. Sayer Ji’s rant is not.

If there’s one lesson that we here at Science-Based Medicine like to emphasize, it’s that practicing medicine and surgery is complicated. Part of the reason that it’s complicated is that for many diseases our understanding is incomplete, meaning that physicians have to apply existing science to their treatment as well as they can. The biology of cancer, in particular, can be vexing. Some cancers appear to progress relentlessly, meaning that it’s obvious that all of them must be treated. Others, particularly when detected in their very early stages through screening tests, have a variable and therefore difficult to predict clinical course if left untreated. Unfortunately, some people, such as Sayer Ji, don’t understand that. They like their medicine black and white, and if physicians ever change guidelines in order to align them more closely with scientific understanding, they write blisteringly ignorant articles like “‘Oops… It Wasn’t Cancer After All,’ Admits The National Cancer Institute/JAMA.”

Not exactly. An expert panel recommended reclassifying a specific thyroid lesion as not cancerous based on recent science. It’s called medicine correcting itself. Admittedly, this reclassification was probably long overdue, but what would Mr. Ji rather have? Medicine not correcting itself in this situation? In any case, when last I met Mr. Ji, he was happily abusing the science of genetics to argue that Angelina Jolie and other carriers of deleterious cancer-causing mutations don’t need prophylactic surgery because lifestyle interventions will save them through epigenetics, which to “natural health” enthusiasts like Mr. Ji seems to mean the magical ability to prevent any disease. Most recently, he has appeared on the deeply dishonest “documentary” about alternative medicine cancer cures, The Truth About Cancer, to expound on how chemotherapy is evil. His rant about the reclassification of a non-encapsulated follicular variant of papillary thyroid cancer as not cancer is more of the same, as you will see.

Posted in: Cancer, Politics and Regulation, Public Health

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NCCIH Strategic Plan 2016-2021, or: Let’s try to do some real science for a change

It’s no secret that we at Science-Based Medicine (SBM) are not particularly fond of the National Center for Complementary and Integrative Health (NCCIH). Formerly known as the National Center for Complementary and Alternative Medicine (NCCAM) and before that the Office of Alternative Medicine, NCCIH has been the foremost government agency funding research into quackery for the last 24 years, and, of course, that’s the reason we at SBM have been harshly critical of NCCIH since SBM’s inception. Basically, NCCIH not only funds studies of dubious “alternative” therapies, but it also promotes quackery by funding “fellowships” at various institutions to teach “integrative medicine,” or, as we like to call it, “integrating” quackery with real medicine.

Indeed, back in 2009, when President Barack Obama first took office, Steve Novella and I both suggested that the time was ripe for NCCIH to be defunded and its functions allowed to revert back to the already existing Institutes and Centers of the National Institutes of Health. We were under no illusions that this would happen, given that NCCIH always had a powerful protector in the man who was arguably more responsible for creating NCCIH and guarding it against all attempts at defunding or, even worse, forcing it to do more rigorous science, woo-loving Senator Tom Harkin (D-IA). Harkin is no longer in the Senate, having retired at the end of 2014, but NCCIH is still with us, and the nature of government makes it very much that, unless someone with power is willing to expend serious political capital to eliminate it, NCCIH will be with us always, no matter how much it tries to change its name to eliminate anything implying pseudoscience.

So those of us who recognize that NCCIH was created to promote the “integration” of “outside of the mainstream” or “unconventional” treatments (the vast majority of which are quackery) into real medicine have to learn to live with NCCIH and, as much as it might gall us, to try make lemonade out of the lemon by prodding it to doing some actual rigorous science on “complementary and alternative medicine” that have at least a modicum of biological plausibility and avoid wasting taxpayer money on fairy dust treatments whose precepts either violate the laws of physics (e.g., reiki, homeopathy, and other “energy” medicine) or depend on nonexistent anatomy or physiology (e.g., reflexology, craniosacral, traditional Chinese medicine tongue diagnosis).

This brings me to something I saw on the NCCIH Director’s Blog late last week, a post by the director Josephine Briggs, Requesting Comments on NCCIH’s Draft Strategic Plan. Patriotic US citizen and advocate of SBM that I am, how could I turn down such a request? Kimball Atwood didn’t shirk from such a request back when Dr. Briggs was asking for comments on the NCCAM 2011-2015 strategic plan, nor did I.

In fact, you, too, can comment as well. The deadline is April 15.

Posted in: Basic Science, Clinical Trials, Politics and Regulation

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April Fool Cannot Surpass SCAM

Stick some coffee up the tailpipe and you've got yourself some complementary and alternative auto care!

Stick some coffee up the tailpipe and you’ve got yourself some complementary and alternative auto care!

It’s April Fools’ day in the US of A. One of the internet traditions is to come up with a story that is weird or unlikely, but not so weird or unlikely that it is not believable, in order to fool people that the story is real.

I gave it the old SBM try, I really did, but I couldn’t do it. I wanted to come up with a SCAM therapy so weird, so unlikely, that I could not find an example of it actually being practiced.

It can’t be done. Like a Trump utterance*, you can’t invent a SCAM (Supplements, Complementary and Alternative Medicine) that someone, somewhere, has already pulled out of, er, well, thin air and are using it on patients.

Of course, what would you expect given that many SCAMs were in fact, pulled out of, er, well thin air. Think chiropractic and DD Palmer, iridology by August von Peczely, and reiki by Mikao Usui. Making up fantastical stuff is what they do.

But even within the spectrum of pseudo-medicine there are those are practices and papers that are so bizarro they should be an April Fools’ joke. But are not. It may be a matter of taste, what one person considers wack-a-loon another would find imminently reasonable. There are certainly assigned delegates that prove that assertion. But even within the wack-a-loon world of SCAM, there are those practices and papers that are more wack-a-loon than others and should be April Fools’ jokes. Maybe it is like more unique. Unique is one of a kind, so something can’t be more one of a kind. More wack-a-loon? Such is the world of SCAM. (more…)

Posted in: Acupuncture, Energy Medicine, Homeopathy, Medical devices, Naturopathy, Politics and Regulation, Science and Medicine

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Regulating CAM Aussie Style

CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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The hijacking of evidence-based medicine

One of our heroes at SBM: John Ioannidis.

One of our heroes at SBM: John Ioannidis.

It’s no secret that I’m a fan of John Ioannidis. So, I daresay, are pretty much all of the editors and regular contributors to this blog. (If you don’t believe me, just type Ioannidis’ name into the blog search box and see how many posts you find.) Over the last couple of decades, Ioannidis has arguably done more to reveal the shortcomings of the medical research enterprise that undergirds our treatments, revealing the weaknesses in the evidence base and how easily clinical trials can mislead, than any other researcher. Indeed, after reading what is Ioannidis’ most famous article, “Why Most Published Research Findings Are False“, back in 2005, I was hooked. I even used it for our surgical oncology journal club at the cancer center where I was faculty back then. This was long before I appreciated the difference between science-based medicine (SBM) and evidence-based medicine (EBM). So it was with much interest that I read an article by him published last week and framed as an open letter to David Sackett, the father of evidence-based medicine, entitled “Evidence-based medicine has been hijacked: a report to David Sackett.” Ioannidis is also quoted in a follow-up interview with Retraction Watch.

Before I get to Ioannidis’ latest, I can’t help but point out that, not surprisingly, quacks and proponents of pseudoscientific and unscientific medicine often latch on to Ioannidis’ work to support their quackery and pseudoscience. They’ve been doing it for years. Certainly, they’re already latching on to this article as vindication of their beliefs. After all, their reasoning—if you can call it that—seems to boil down to: If “conventional” medicine is built on such shaky science, then their pseudoscience isn’t wrong after all, given that the same scientific enterprise upon which conventional medicine is based produces the findings that reject their dubious claims and treatments. Of course, whenever I hear this line of argument, I’m reminded of Ben Goldacre’s famous adage, seen in one form on Twitter here:

The adage can be generalized to all EBM and SBM as well. Just because big pharma misbehaves, EBM has flaws, and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy, acupuncture, or energy medicine works.

Still, when Ioannidis publishes an article with a title provocatively declaring that EBM has been “hijacked,” we at SBM take notice. (more…)

Posted in: Basic Science, Clinical Trials, Medical Academia, Pharmaceuticals, Politics and Regulation

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Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]


Posted in: Clinical Trials, Ethics, Legal, Pharmaceuticals, Politics and Regulation

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Reporting results from clinical trials is vital for science-based medicine

Real medicine is built on high quality data. That’s one lesson I learned through my rehabilitation as a former naturopath. I can assure you that this principle does not apply to naturopathy or any of the other types of alternative medicine, which are mostly based on anachronistic traditions, magical thinking, and poor academic integrity. I now know that real medicine incorporates any therapy scientifically demonstrated to be effective and safe, regardless of origin. Therapies that fail to demonstrate effectiveness remain alternative for good reason.

I made a sharp turn in my career when I realized this, but I was recently surprised to learn that a failure to respect the data can sometimes also characterize medicine. I’m not trying to fool anyone with an appeal to hypocrisy (often used by alternative medicine zealots to argue that their beliefs are somehow valid simply because medicine has problems). But I do want to draw attention to a problem with medical research, which has the potential to undermine science-based medicine and take us down the dark path of misinformed medicine — medicine based on incomplete data.


Most people probably don’t realize that a majority of clinical trials do not report their findings.[1–3] About half of trials conducted before 2007, before it was legally required to register and report clinical trials, have never been published.[4, 5] Even since stronger legal mandates were enacted, most clinical trials still are not registered or reported.[1–3] As a result, there is a huge amount of clinical data unknown to the medical community and not available to clinicians or patients.

This effectively means that medical decisions can be based on incomplete information, not only diminishing the effectiveness of treatments but also eroding the perceived plausibility of medical interventions over time. This is what Sense About Science’s AllTrials campaign is all about: ensuring that all clinical trials register and report results in a publicly-available database. I see it as an obvious and straightforward means to improve medicine. (more…)

Posted in: Clinical Trials, Ethics, Naturopathy, Politics and Regulation, Quality Improvement, Science and Medicine

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